Fda

Successfully meet/ complete training milestones relevant to the position held. - Familiarity with FDA and ICH guidelines, Life Sciences & Pharmaceutical industry - Good knowledge on FDA, GCPs, ICH guidelines, Life Sciences and Pharmaceutical Industry. - Familiarity of health authority procedures / guidance regarding electronic submissions - Perform...

The **Software Quality Validation Engineer** position that supports quality systems activities related to software validation, with a focus on design control and risk management in accordance with FDA and ISO regulations. This position contributes to the completion of milestones associated with software projects or activities using existing procedures and...

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Principal Statistical Programmer on a permanent basis. You will work on projects from our varied client base,...

**Job Responsibility**: **Primary Responsibilities**: This job description is intended to provide a general overview ofthe job requirements at the time it was prepared. The job requirements of any position maychange over time and may include additional responsibilities not specifically described in thejob description. Consult with your supervision regarding...

Responsibilities:- Oversee the maintenance operations of the pharmaceutical plant, ensuring all equipment and facilities are in optimal condition.- Develop and implement preventive and predictive maintenance programs.- Ensure compliance with GMP, FDA, and other regulatory requirements.- Manage maintenance staff, providing training and guidance to ensure high...

Responsibilities:- Oversee the entire operation of the pharmaceutical OSD plant, ensuring production targets are met within quality and regulatory standards.- Develop and implement operational strategies to improve efficiency and productivity.- Ensure compliance with GMP (Good Manufacturing Practices), FDA regulations, and other relevant industry standards.-...

Responsibilities:Oversee the maintenance operations of the pharmaceutical plant, ensuring all equipment and facilities are in optimal condition.Develop and implement preventive and predictive maintenance programs.Ensure compliance with GMP, FDA, and other regulatory requirements.Manage maintenance staff, providing training and guidance to ensure high...

Responsibilities:Oversee the maintenance operations of the pharmaceutical plant, ensuring all equipment and facilities are in optimal condition.Develop and implement preventive and predictive maintenance programs.Ensure compliance with GMP, FDA, and other regulatory requirements.Manage maintenance staff, providing training and guidance to ensure high...

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and...

Responsibilities:Oversee the entire operation of the pharmaceutical OSD plant, ensuring production targets are met within quality and regulatory standards.Develop and implement operational strategies to improve efficiency and productivity.Ensure compliance with GMP (Good Manufacturing Practices), FDA regulations, and other relevant industry standards.Manage...

Responsibilities:Oversee the entire operation of the pharmaceutical OSD plant, ensuring production targets are met within quality and regulatory standards.Develop and implement operational strategies to improve efficiency and productivity.Ensure compliance with GMP (Good Manufacturing Practices), FDA regulations, and other relevant industry standards.Manage...

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Principal Biostatistician on a permanent basis. You will work on projects from our varied client base, ranging...

**Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.** At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates...

**Job Title**: Mobile QA Automation Architect **Essential Duties/Responsibilities** - Work with contract junior QA engineers assigned across products and coordinate automation and execution status. - Operates in full compliance with internal policies and procedures as well as applicable regulations and laws, including but not limited to FDA requirements....

**MECHANICAL ENGINEERING INTERN** ABOUT US: ABM Respiratory Care is a medical device company with a product portfolio of respiratory solutions focused on airway clearance and ventilation therapies. Our mission is to advance the healthcare industry by developing intelligent, clinically differentiated, and innovative respiratory care solutions to help people...

**This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

**Job Title**: Data QA Architect Data QA architect **Your role**: - Work with junior QA engineers assigned across products and coordinate automation and execution status. - Operates in full compliance with internal policies and procedures as well as applicable regulations and laws, including but not limited to FDA requirements. Responsible to report any...

Senior/Lead Statistical Programmer Full-Time Bengaluru, Karnataka, India Hyderabad, Telangana, India Description Job Responsibilities: • Annotate Case Report Form ( following FDA/CDISC or sponsor guidelines. • Develop SDTM specifications and generate SDTM datasets using SAS. • Develop ADaM specifications and generate ADaM datasets...

Overview: - MedTech expert with ability to drive innovative digital health / Medtech / therapeutic solutions for clients. - Role: - Develop strategic roadmaps for global clients - in areas MedTech, Digital / Connected Health - Drive Innovation, thought leadership, Knowledge management - Create new offering, assets - collaborating with various technology &...

Senior / Principal Biostatistician Full-Time Bengaluru, Karnataka, India Hyderabad, Telangana, India Description Provide statistical oversight to studies and assure adequate quality and consistency with project requirements. Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so...